Terumo Cardiovascular Systems

Recipient: Terumo Cardiovascular Systems.
Product:Advanced Perfusion System (APS-1)

Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806. For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm to reduce a risk to health posed by the APS-1 device. This field correction included a software update to correct a software defect that could result in incomplete delivery of cardioplegia dose. CDRH evaluation has classified your October 19, 2005 notification to consumers of a software upgrade as a Class II recall indicating a situation in which use of or exposure to the APS-1 presents a remote probability of serious adverse health consequences.

FDA District:Detroit District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.